10/03/2017

The Federal Policy for the Protection of Human Subjects, or the Common Rule was revised earlier this year and is set to be effective on January 19th, 2018. The Common Rule was created in 1991 to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” Departments and agencies including, but not limited to, the Department of Homeland Security, the Department of Health and Human Services and the National Science Foundation made these revisions in an effort to “modernize, simplify, and enhance the current system of oversight.”

According to Dr. Fisher, the first change, stating that investigators are permitted to obtain broad consent from participants for future use of identifiable biospecimens by the original investigator or other investigators, “increases the ability of scientists to combine large data sets to explore important medical questions.” However, she says, “it is unclear whether hacking or the use of the identifiable information…will pose a social or economic risk to participants.” Dr. Fisher continues that it could be additionally problematic if “identifiable data is used to inform policies that promote medical discrimination of already vulnerable groups” without the research participants understanding how their data will be used in the future.

The second revision of the Common Rule that will impact informed consent practices states that investigators are required to give prospective participants a brief summary of “key points” that a reasonable person would want to know to make an informed choice. Dr. Fisher notes that this revision “can be an advantage over the current risk-averse legal language in informed consent materials,” but the revision does not state who will be deciding what the key points are which could be potentially problematic considering participants, investigators and IRB members may have different ideas of what “important information” is.

To read the full article and October’s Issue of Medical Ethics Advisor, please visit their website here. To subscribe to the journal, please visit AHC Media.